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Low FODMAP Diet in Patients With IBS

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
variations of the low FODMAP diet
Sponsored by
Jens Rikardt Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Carbohydrates, low FODMAP diet, components in the low FODMAP diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: IBS diagnosed by the Rome III criteria and referred to treatment by diet - Exclusion Criteria: Dementia, and lack of ability to speak Danish or other conditions prevailing participation -

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

low FODMAP diet

Arm Description

Cross-over design with 3 variations

Outcomes

Primary Outcome Measures

Birmingham IBS questionnaire and adequate relief (IBS-AR).
Score in points

Secondary Outcome Measures

IBS Quality of Life Scale questionnaire (IBS-QOL)
Score in points

Full Information

First Posted
November 8, 2022
Last Updated
November 8, 2022
Sponsor
Jens Rikardt Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT05618106
Brief Title
Low FODMAP Diet in Patients With IBS
Official Title
Modification of the Low FODMAP Diet in Treatment of Irritable Bowel Syndrome: A Randomised Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We aimed to investigate if all carbohydrate groups eliminated in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS. in a randomised cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for three months without wash-out-periods. Gastrointestinal symptoms, Quality of life was measured at baseline and after each intervention diet.
Detailed Description
Low FODMAP diets contain 3 major types of carbohydrates to be avoided. The clasical diet is very difficult to maintain over longer periods of time. Therefore, we aimed to investigate if all carbohydrate groups in the Low FODMAP diet are equally important in relieving gastrointestinal symptoms in IBS. Patients diagnosed with IBS according to the Rome III criteria were randomised in a cross-over design to three different carbohydrate-modified diets: A) Low Polyol diet, B) Low FOS+GOS diet, and C) Low FODMAP diet for a total of three months without wash-out-periods. Gastrointestinal symptoms were assessed by the Birmingham IBS questionnaire and adequate relief (IBS-AR). Quality of life was measured by the IBS Quality of Life Scale questionnaire (IBS-QOL). All registrations were performed at baseline and after each intervention diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Carbohydrates, low FODMAP diet, components in the low FODMAP diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Cross-over of 3 variations of the low FODMAP diet excluding 1 of the 3 components in every period
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low FODMAP diet
Arm Type
Experimental
Arm Description
Cross-over design with 3 variations
Intervention Type
Other
Intervention Name(s)
variations of the low FODMAP diet
Intervention Description
Cross-over of 3 interventions in IBS patients: Low Polyol diet Low FOS+GOS diet Low FODMAP diet
Primary Outcome Measure Information:
Title
Birmingham IBS questionnaire and adequate relief (IBS-AR).
Description
Score in points
Time Frame
3 months
Secondary Outcome Measure Information:
Title
IBS Quality of Life Scale questionnaire (IBS-QOL)
Description
Score in points
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: IBS diagnosed by the Rome III criteria and referred to treatment by diet - Exclusion Criteria: Dementia, and lack of ability to speak Danish or other conditions prevailing participation -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD, MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Low FODMAP Diet in Patients With IBS

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